Pharmacother. Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Killingley, B. et al. Odhar, H. A. et al. The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine. One puff of the respective nasal spray was applied per nostril, 3 times a day (morning, midday, evening). URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany is the sponsor of the clinical trial. and F.H. performed the statistical analysis. https://doi.org/10.1007/s10787-021-00847-2 (2021). Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. Nasal Sprays Could Protect You From Serious COVID-19 Illness To obtain Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). For pairwise comparisons between treatment groups, Mann Whitney U test was performed, and significance levels were adjusted to p<0.0167 based on the Bonferroni correction. The study was funded by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany and CEBINA GmbH Vienna, Austria. Dings, C. et al. However, the overall small number of participants limits conclusions, and results should be interpreted with care. Importantly, newly emerging virus variants have the potential to evade the immune response, thereby affecting the efficacy of specific therapies and underlining the importance of new treatment strategies. The spritz developed by Moscona's team is one of a raft of proposed nasal sprays to prevent SARS-CoV-2 infection. SARS-CoV-2 infection progression starts with viral entrance mediated by the spike glycoproteins interaction with the host ACE2 receptor molecule. A complete list of inclusion and exclusion criteria is presented in Table 1. https://doi.org/10.1038/s41401-020-00556-6 (2020). The analysis of sum symptom scores showed that the study population (ITT analysis set) suffered from moderate symptoms (mean valuesSD: 38.5810.04) on day 1 of the study (supplementary Table S5). Lee, C. & Corren, J. Pharmacol. Ku Z, Xie X, Hinton PR, Liu X, Ye X, Muruato AE, Ng DC, Biswas S, Zou J, Liu Y, Pandya D, Menachery VD, Rahman S, Cao . Reznikov et al. The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). Cornell research team to develop COVID-19 nose spray treatment. How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. Symptoms were evaluated on a 5-point scale from 1=symptom absent or present very weakly to 5=symptom present very strongly: anosmia, ageusia, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limb, loss of appetite, pneumonia, nausea, abdominal pain, vomiting, diarrhea, conjunctivitis, rash, lymph node swelling, apathy, somnolence. As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. 4). Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older. June 10, 2022 at 2:00 pm. C.A. Evaluation of AUC values (reflecting baseline adjusted decreases of viral load over 11days) showed that the 0.1% azelastine group exhibited a greater AUC value of 24.1413.12 (referring to greater decrease) compared to the placebo group with an AUC value of 18.894.70 (p=0.007, Fig. The sprays would be fast-acting and would be applied frequently, perhaps once or. Nature (Nature) 19(10), 16. Quality of life was assessed with the SF-36 questionnaire as no COVID-19 specific patient-reported outcome measures were available at the time of study. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. https://doi.org/10.1080/14787210.2021.1908127 (2021). J. Infect. Nature 602, 676681. Asthma Allergy Immunol. Shmuel, K., Dalia, M., Tair, L. & Yaakov, N. Low pH Hypromellose (Taffix) nasal powder spray could reduce SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: An observational prospective open label user survey. It should be noted that the SARS-CoV-2 alpha variant (B.1.1.7) was the dominant variant in Germany during the enrolment phase of the current study16. Many elderly people as well asindividuals who are immunodeficient for various reasons do not respond to vaccines, and are in the need of other protective measures, said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki. was responsible for the patient disposition. You can also search for this author in PubMed also provided experimental evidence for the inhibition of the enzyme in a kinetic activity assay7. In the meantime, to ensure continued support, we are displaying the site without styles Researchers at Swansea University will begin human trials this week following a successful study suggests the 5.99 remedy, Dual Defence, could help reduce infections thanks to its special ingredient - seaweed . Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti A summary of study activities is displayed in Table 2. The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. Of note, in vitro tests carried out prior to the current study did not indicate any interaction between the study products and the PCR reaction (see supplementary PCR data). Winchester, S., John, S., Jabbar, K. & John, I. Patients aged 18 to 60years were eligible to participate if tested positive for SARS-CoV-2 in a Corona test centre by PCR test within 48h prior to inclusion and had to quarantine at home due to instructions of the local health authority. Gottlieb, R. L. et al. The median/mean viral load value (ORF 1a/b gene) of the ITT analysis set at enrolment was log10 7.23/6.851.31 cp/mL (approximately 7 million viral copies per mL, the highest values being~540 million cp/mL). The team will enrol 480 healthworkers, including nurses and doctors . Article When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385. Treatment of COVID-19 with a hypertonic solution containing seawater, xylitol, panthenol and lactic acid was shown to reduce the viral shedding time in patients with asymptomatic or mild COVID-1920, whereas application of povidone iodine nasal spray showed only poor influence on SARS-CoV-2 viral titres21,22. Marc, A. et al. Both have the allure of being variant-proof, Topol added., Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called "nanobodies" because they are more cost-effective and are able to last longer in storage, Mkel and colleagues noted., Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2.. It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. SARS-CoV-2 RNA levels in nasopharyngeal swabs were determined by quantitative RT-PCR using the cobas SARS-CoV-2 Test on the cobas 6800 system (Roche Diagnostic, Mannheim, Germany). JAMA Otolaryngol. Amdal, C. D. et al. Virol. Comirnaty is also authorized . While PCR results in the placebo group turned negative only on day 11 of treatment, individual patients of the 0.1% azelastine group already showed negative PCR test results from day 2 on. In addition, intervals between swab sampling were short and the overall number of performed PCR tests was high to allow a very close determination of the viral clearance. Samples of day 1 represent pre-treatment baseline samples. TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reducethe risk of severe COVID-19 disease, she said.. Coronavirus: how to protect yourself and others, plus what - Which? Nasal spray that protects against COVID-19 is also effective against the common cold . Nature 581, 465469. https://doi.org/10.1038/s41586-020-2196-x (2020). Bearing in mind the low number of participants in the current proof-of-concept study, the results still build a promising foundation for a currently running phase III study, during which effects of azelastine nasal spray on symptom severity and progression to severe COVID-19 disease are investigated in a greater patient population. Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. The product targets a stable site on the spike protein of the virus that is not known to mutate. At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. 4). The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). and JavaScript. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. Short intervals of swab collection time points, particularly during early days of infection, and high number of PCR tests aimed to monitor SARS-CoV-2 viral loads as closely as possible, considering that only limited knowledge regarding details of viral clearance was publicly available at the time of the study development. . & Ware, J. The most common COVID-19 symptoms (loss of sense of smell, loss of taste, fever, cough, and coryza) improved over time in all 3 treatment groups; and no statistical differences were observed between groups. In addition, investigators measured body temperature during V1V7 and oxygen saturation of the blood (using a finger pulse oximeter) on V1, V3, and V5, V6 and V7. ADS 62, 50937, Cologne, Germany, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 538, 173179. Nat. Google Scholar. Study finds nasal spray could aid battle against COVID June 16, 2022, U.S. Department of Health and Human Services, The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Our study showed both strengths and limitations. Nat. 384, 671673. Bioinformation 16, 236244. This trial was conducted at the Department of Otorhinolaryngology, Head and Neck Surgery of the Faculty of Medicine of the University of Cologne, Germany. Anticipating a drop-out rate of 20%, the aim was to randomize 90 patients in total (30 patients per treatment group) to result in 23 patients per treatment group completing the study and being eligible for analysis. Researchers supported in part by the National Institute of Allergy and Infectious Diseases (NIAID) have developed a nasal spray that has the potential to not only treat COVID-19 but also prevent SARS-CoV-2 infection in a way that the virus cant mutate to avoid. Chem. 20, e192e197. Cegolon, L. et al. Those compounds were tested in human lung and colon cells that were then exposed to SARS-CoV-2. Klussmann, J.P., Grosheva, M., Meiser, P. et al. Asthma inhalers: Which one's right for you? - Mayo Clinic The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Article Med. The Impact of Opioid Use Disorder Services on Overdose Deaths, Access to telehealth and medications for opioid use disorder during the pandemic reduced drug overdose deaths, Bivalent Boosters Offer Better Protection Against Omicron, Updated boosters are more effective at preventing severe COVID-19 from the most common SARS-CoV-2 variant, Page last updated: The improvement of the symptom shortness of breath was significantly greater on days 3 (p=0.004) and 4 (p=0.011) in the 0.1% azelastine group compared to placebo (supplementary Figure S3). Anti. 48.9% (n=44) of the safety analysis set was male, and the average age was 35.6712.94years. analyzed 219,000 medical records in a retrospective data base survey study and demonstrated that azelastine showed the highest association between prior usage among these antihistamines and SARS-CoV-2 negative test results in patients above the age of 60 (OR: 2.43; 95% CI: 1.474.02). Sin. ISSN 1476-4687 (online) Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. This was a prospective, randomized, double-blind, placebo-controlled dose-finding proof-of-concept study, in which azelastine nasal spray was used in 2 doses: the commercially available concentration of 0.1% and a fivefold lower concentration of 0.02%. COVID-19 nasal sprays may one day prevent and treat infection - ABC Rev. https://doi.org/10.1001/jamaoto.2020.5490 (2021). Could a nose spray a day keep COVID away? - nature.com Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. Thus, it should be kept in mind that treatment started at a time point where the peak of viral load had probably passed. It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. Instructions for storing, preparing, and administering the study treatment will be provided to participants. Additionally, 0.02% azelastine nasal spray and 0.1% azelastine nasal spray were formulated by the addition of 0.2mg/mL or 1mg/mL azelastine hydrochloride, respectively. The RBD is where the coronavirus attaches to cells in the body. The efficacy of the treatment was judged as good or very good by 75.0% (0.1% azelastine treatment), 74.1% (0.02% azelastine treatment) and 50.0% (placebo treatment) of patients. Patient disposition. Trials under way to see if Boots nasal spray can prevent Covid-19 ICE-COVID a randomised, double blind, placebo-controlled phase III trial of the prophylactic efficacy of iota-carrageenan nasal and throat spray in preventing COVID-19 illness in at risk healthcare professionals. When treated with N-0385, 70% of the mice survived and had little to no lung damage. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. Slider with three articles shown per slide. The experimental drug works in mice, and researchers believe it may be effective in humans. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). March 31, 2023 - An antiviral therapy in early development has the potential to prevent COVID-19 infections when given as a nasal spray as little as 4 hours before exposure. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. https://doi.org/10.1001/jama.2021.0202 (2021). Jean, F. (2022). Article H.G., M.S., and F.K. BR, SMS, HS, CA, NW, SA, and RM are employees of ClinCompetence Cologne, the CRO which organized this trial. The current study was a randomized, parallel, double-blind, placebo-controlled trial. The overall AUC of the Azelastine 0.1% group (red area) was significantly greater than that of placebo (green area), p=0.007. ISSN 0028-0836 (print). Patient reported outcomes were documented by patient diaries and questionnaires. 5) Of note, these differences were not statistically significant (p=0.112). Multinomial regression analysis was done to 26 determine the association between nasal carriage of Bacillus and COVID-19 severity after 27 adjusting for age, sex, and co-morbidity status. 27, 790792. Boots cold and flu nasal spray that costs just 6 could stop - The Sun https://doi.org/10.1038/s41586-021-04388-0 (2022). PubMed Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. Components are mixed from two chambers to create the final NO-producing formulation. Scientific Reports (Sci Rep) Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 Monoclonal antibodies can block SARS-CoV-2 from . New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? . Overall, no significant differences were observed between treatment groups regarding gender, age and body mass index (bmi, supplementary Table S1). One study of about 400 health-care workers suggests a nasal spray may reduce the incidence of COVID-19 by up to 80 per cent. It's being studied as a potential way to prevent mild to moderate cases of COVID-19. Sci Rep 13, 6839 (2023). Inhibition of SARS-CoV-2 by bentonite-based nasal spray. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. The Ct<25 group consisted of 19 patients in the 0.1% azelastine group, 21 patients in the 0.02% azelastine group and of 17 patients in the placebo group (Fig. At the end of the study, patients and investigators assessed the overall tolerability and efficacy of the treatment as very good (3), good (2), moderate (1) or poor (0). Both descriptive and exploratory statistics were performed. https://doi.org/10.1056/NEJMc2027040 (2021). By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. 90 patients were recruited between 09/03/2021 and 28/04/2021, constituting the safety analysis set. Inhibition of leukotriene synthesis by azelastine. ITTintention to treat. We would like to thank Prof. G.A. 62, 50937, Cologne, Germany, You can also search for this author in Initial viral loads were log10 6.851.31 (meanSD) copies/mL (ORF 1a/b gene). CofixRx, LLC - 626860 - 04/05/2022 | FDA JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. But vaccines are fighting a changing opponent. PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. The preventive application of a hydroxypropyl methyl cellulose nasal spray showed promising results in an observational survey, indicating that it may reduce SARS-CoV-2 infection rates19. Lee, K. (2022, April 27). Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. The nasal spray is comprised of xylitol and GSE (Grapefruit Seed extract) which provides antibacterial properties as well as preventing viral adhesion in the nasal passage.